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Ethical issues in Medical Research

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Ethical issues in Medical Research Dr. Anjum Susan John , MD 10/3/2009 * Medical Research Center , HMC, Doha , Qatar * * Medical Research Center, Doha, Qatar ... – PowerPoint PPT presentation

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Title: Ethical issues in Medical Research


1
Ethical issues in Medical Research
  • Dr. Anjum Susan John , MD
  • 10/3/2009

2
Objectives
  • Trace the development of ethical codes by
    discussing some of the unethical studies
    documented in literature
  • What are ethics ?
  • Discuss the 3 features of research ethics
  • Focus of research ethics over the decades
  • 21st century focus of research ethics
  • Critique the ethical aspects of a study

3
Objective 1 first part
  • To trace the development of ethical codes

Hippocrates
4
Hypothermia studies in the 1940s
  • Research subjects were immersed in bath
    temperatures of 2-12C.
  • A sub group of them were immersed in ice water
    tanks
  • They were then made to stand outside , some with
    and some without clothes , and their bodys
    reactions to cold observed and measured

5
What did researchers want to determine in this
instance ?
  • How long does it take for body parts to freeze
    when people are kept naked outdoors in sub
    freezing temperatures ?
  • What signs symptoms are seen when people are
    kept in tanks of ice water for 3 hours ?

6
Medical Experiments - 1933 -1945
  • On prisoners by exposing them to high
    altitudes, malaria, poisons, typhus, untested
    drugs and operations( without anesthesia)

7
Why did these researchers conduct these
experiments ?
  • Who were the people on whom these experiments
    were conducted ?

8
What happens to the healthy human body when
.?
  • It is inoculated with live germ causing bacteria
    (disguised like vaccinations )like typhoid or
    paratyphoid ?
  • Clothes from plague victims were dropped on it ?
  • When wounds were infected with spores of tetanus
    ?
  • The subjects for these experiments were
    civilian and military people from China, Korea,
    Mongolia and Russia , held as prisoners .
  • Experiments by Dr. Shiro Ishii in Japan The
    truth about unit 731)

9
What do you think .
  • were the issues in these cases ?

10
Objective 1- second part
  • Discuss some of the unethical studies documented
    in literature

11
Handouts
  • Research on prediction of skeletal size in
    Germany
  • Research on human endurance to pain in Japan
  • Tuskegee case in the USA
  • Case of Edward Jenner and the small pox vaccine
  • Willow brook case

12
Skeletal size experiments
  • What are the issues ?

13
Atrocities committed In Japan
  • What were the issues ?

14
Tuskegee syphilis study
  • Issues ?
  • Where were the government and health care systems
    that should have stopped this unethical study
    from continuing for 40 years ?

15
Edward Jenner
  • Deliberately exposed an 8 year old boy to cowpox
    to try out his new vaccine for smallpox
  • Issues ?

16
Willow brook study(1950s to 1970s)
  • Issues ?
  • Researchers stressed the benefits the children
    would receive- cleaner environment, better
    supervision and a higher nurse /patient ratio on
    the research ward

17
Nuremberg trials
18
Development of Ethical Codes
  • Nuremberg code, 1947(http//en.wikipedia.org/wiki/
    Nuremberg_code )
  • Helsinki Declaration 1965, rewritten
    1975-WHO(http//www.wma.net/e/ethicsunit/helsinki.
    htm )
  • Belmont report of the national commission for the
    protection of human subjects of biomedical and
    behavioral research , 1979(http//www.bop.gov/news
    /BelmontReport.jsp )
  • CIOMS guidelines ,Council for international
    organizations of medical sciences
    2002(http//www.cioms.ch/frame_guidelines_nov_2002
    .htm )

19
Helsinki declaration(1964)
Nuremberg code, 1947
Informed consent
Benefit Vs Risk assessment
Subject interest gtSociety interest
IRB approval
Result accuracy
20
Nuremberg Code Helsinki Declaration
  • Voluntary consent
  • Withdrawal of subjects
  • Balance of risks and benefits
  • Differentiated between therapeutic and non
    therapeutic research

21
Belmont Report of 1979
  • Was developed in response to the Tuskegee and
    Willow brook controversies

22
Objective 2
  • What are ethics ?

23
What are ethics ?
  • These include all the rules and principles that
    determine which actions are right and which are
    wrong.

24
Objective 4
  • Discuss the 3 features of research ethics

25
Ethical principles guiding researchers (National
Commission for the protection of human subjects
of biomedical and behavioral research-1978)
  • Respect for human dignity
  • Beneficence
  • Justice
  • ( Belmont Report )
  • Ethical approval of a project depends on the
    degree to which the researcher plans to protects
    the rights of the patients.

26
1 Respect for human dignity
  • Element 1 Right to full disclosure
  • Informed consent
  • Element 2 Right to self determination

27
Violation of right to self determination ????
  • Coercion
  • Inclusion in studies without subject knowledge of
    participation
  • Deception

28
Special case situations
  • Individuals with diminished autonomy

29
2 Principle of beneficence
  • Element 1 Freedom from harm
  • Element 2 Freedom from exploitation

30
3 Principle of justice
  • Element 1 Right to fair treatment
  • Element 2 Right to privacy
  • Anonymity
  • Confidentiality

31
Objective 4
  • Changing focus of research ethics over the decades

32
Changing focus of research ethics
  • In the 1970s and 1980s, research ethics
    guidelines focused on the protection of rights of
    vulnerable populations like children
  • In the 1990s and the 2000s, the focus is on
    promoting research participation of all
    subjects, including vulnerable subjects.

33
Objective 5
  • Where does research ethics stand in the 21st
    century?

34
Ethical issues in modern day research
  • The use of control arms (placebo)
  • Standard of care
  • Informed consent process
  • Community consultation
  • Individual and community access to research
  • The role responsibility of ethics committees
    (ECs)
  • Compensation for trial injury
  • Patient/Participant Confidentiality and Privacy
  • Locating phase I, II, and III trials
  • Medical treatment during the course of research
  • Product availability
  • Sponsorship
  • Liability Insurance
  • Tissues
  • Stem Cell Research
  • Gene Transfer
  • Data Protection
  • Monitoring (DSMBs)
  • Publication issues
  • Data Ownership
  • Proprietary Information/Knowledge
  • Botanical/Traditional Medicines

35
21st century ethical issues
Human guinea pigs ???
36
Cloning and ethics ???
  • Cloning ????

37
Objective 6
  • How to critique the ethical aspects of a research
    ?

38
Critiquing ethical aspects of a study
  • IRB approval ?
  • Respect for human dignity
  • Autonomous decision 2. full disclosure 3.
    informed consent
  • Beneficence
  • Any harm 2. exploitation/coercion 3. benefit gt
    risk
  • Justice
  • 1. Fair treatment 2. right to privacy
    /confidentiality / anonymity

39
Summary
  • How and why were ethical codes developed ?
  • What are the principles of research ethics ?
  • Critically appraise ethical aspects of a study

40
The best approach
  • is to prevent ethical problems from arising in
    the first place.
  • -Tom Regan, North Carolina State University

41

42
Thank you
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